Label: SIMPLEX- passiflora incarnata, ignatia amara, valeriana officinalis tablet

  • NDC Code(s): 34666-008-06, 34666-008-60
  • Packager: Nartex Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 27, 2018

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  • ACTIVE INGREDIENT

    Passiflora incarnata

    Ignatia amara

    Valeriana officinalis




  • INDICATIONS & USAGE

    For relief of symptoms of sleeplessness and stress as per homeopathic materia medica

  • PURPOSE

    Passiflora incarnata.............Nervousness, sleeplessness

    Ignatia Amara.....................Sleeplessnes, worry

    Valeriana oficinalis..............Sleeplessness

  • WARNINGS

    Do not:

    • use if you have an allergy or hypersensitivity to components of the formula
    • give to children under 12 years of age

  • STOP USE

    Stop use and ask a doctor if:

    • discomfort persists
    • sleeplessness persists continuously for more than 2 weeks.  Insomnia may be a symptom of serious underlying medical illness
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding:

    • ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • adults take 2 orally every 4 hours during the day.  Dissolves slowly in mouth.
  • STORAGE AND HANDLING

    store in a cool and dry place

  • INACTIVE INGREDIENT

    Gelatin, Lactose, Magnesium Stearate, Potato Starch, Sodium Benzoate, Talc

  • QUESTIONS

    Questions or Comments?

    P.O. Box 1261, Downey CA 90240

    52+(871) 721.0855

    www.Nartexlabs.com

  • PRINCIPAL DISPLAY PANEL

    Relieves symptoms of Sleeplessness and Stress

    Simplex Front Carton

    Simplex Back Carton







  • INGREDIENTS AND APPEARANCE
    SIMPLEX 
    passiflora incarnata, ignatia amara, valeriana officinalis tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER3 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED3 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-008-6060 in 1 BOX; Type 0: Not a Combination Product12/23/2010
    2NDC:34666-008-066 in 1 BOX; Type 0: Not a Combination Product12/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/23/2010
    Labeler - Nartex Laboratories (589914576)
    Registrant - Nartex Laboratories (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nartex Laboratories589914576manufacture(34666-008)
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